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LEVITRA Drug Profile
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Which patents cover Levitra, and what generic alternatives are available?
Levitra is a drug marketed by Bayer Hlthcare and is included in one NDA. There are two patents protecting this drug and three Paragraph IV challenges.
This drug has fifty-four patent family members in thirty-one countries.
The generic ingredient in LEVITRA is vardenafil hydrochloride. There are six drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the vardenafil hydrochloride profile page.
US ANDA Litigation and Generic Entry Outlook for Levitra
A generic version of LEVITRA was approved as vardenafil hydrochloride by TEVA PHARMS on May 3rd, 2012.
Summary for LEVITRA
| International Patents: | 54 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 2 |
| Bulk Api Vendors: | 63 |
| Clinical Trials: | 24 |
| Patent Applications: | 1,836 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for LEVITRA |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for LEVITRA |
| DailyMed Link: | LEVITRA at DailyMed |
Recent Clinical Trials for LEVITRA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Tritech Biopharmaceuticals Co., Ltd. | Phase 1/Phase 2 |
| A2 Healthcare Taiwan Corporation | Phase 1/Phase 2 |
| Azienda USL Modena | Phase 2 |
Pharmacology for LEVITRA
| Drug Class | Phosphodiesterase 5 Inhibitor |
| Mechanism of Action | Phosphodiesterase 5 Inhibitors |
Paragraph IV (Patent) Challenges for LEVITRA
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| LEVITRA | TABLET;ORAL | vardenafil hydrochloride | 021400 | 2009-09-04 |
| LEVITRA | TABLET;ORAL | vardenafil hydrochloride | 021400 | 2009-07-10 |
| LEVITRA | TABLET;ORAL | vardenafil hydrochloride | 021400 | 2009-03-05 |
US Patents and Regulatory Information for LEVITRA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Bayer Hlthcare | LEVITRA | vardenafil hydrochloride | TABLET;ORAL | 021400-003 | Aug 19, 2003 | DISCN | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Bayer Hlthcare | LEVITRA | vardenafil hydrochloride | TABLET;ORAL | 021400-004 | Aug 19, 2003 | AB | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | |||
| Bayer Hlthcare | LEVITRA | vardenafil hydrochloride | TABLET;ORAL | 021400-001 | Aug 19, 2003 | AB | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | ||
| Bayer Hlthcare | LEVITRA | vardenafil hydrochloride | TABLET;ORAL | 021400-004 | Aug 19, 2003 | AB | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | ||
| Bayer Hlthcare | LEVITRA | vardenafil hydrochloride | TABLET;ORAL | 021400-003 | Aug 19, 2003 | DISCN | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for LEVITRA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Bayer Hlthcare | LEVITRA | vardenafil hydrochloride | TABLET;ORAL | 021400-001 | Aug 19, 2003 | Start Trial | Start Trial |
| Bayer Hlthcare | LEVITRA | vardenafil hydrochloride | TABLET;ORAL | 021400-003 | Aug 19, 2003 | Start Trial | Start Trial |
| Bayer Hlthcare | LEVITRA | vardenafil hydrochloride | TABLET;ORAL | 021400-004 | Aug 19, 2003 | Start Trial | Start Trial |
| Bayer Hlthcare | LEVITRA | vardenafil hydrochloride | TABLET;ORAL | 021400-002 | Aug 19, 2003 | Start Trial | Start Trial |
| Bayer Hlthcare | LEVITRA | vardenafil hydrochloride | TABLET;ORAL | 021400-004 | Aug 19, 2003 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for LEVITRA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Czech Republic | 301911 | Start Trial |
| Portugal | 1523303 | Start Trial |
| Spain | 2386420 | Start Trial |
| Ecuador | SP055541 | Start Trial |
| Lithuania | 2272505 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
